Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

ClinicalTrials.gov Identifier: NCT02422615

Novartis Reference Number: CLEE011F2301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.

Condition 
Advanced Breast Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
726 participants
Start date 
Sep 14, 2014
Completion date 
Feb 21, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ribociclib
Ribociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle)
Drug
fulvestrant
Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
Drug
Ribociclib placebo
Ribociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle)

Eligibility Criteria

Inclusion Criteria:

Patient is an adult male/female ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer.
Patient must have either measurable disease by RECIST 1.1 or at least one predominantly lytic bone lesion.

Patient has advanced (loco regionally recurrent not amenable to curative therapy, e.g. surgery and/or radiotherapy, or metastatic) breast cancer.

Patients may be:

newly diagnosed advanced/metastatic breast cancer, treatment naïve
relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease
newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor)
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient has adequate bone marrow and organ function

Exclusion Criteria:

Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.
Patient with inflammatory breast cancer at screening .
Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion to starting the study treatment and have stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality

Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to start the treatment:

Known strong inducers or inhibitors of CYP3A4/5,
That have a known risk to prolong the QT interval or induce Torsades de Pointes.
Those have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
Herbal preparations/medications, dietary supplements.

Other Protocol-defined Inclusion/Exclusion may apply.

Study Locations

United States
Southern Cancer Center PC SC-2
-
Mobile, 36608
Alabama
United States
Ironwood Cancer and Research Centers SC-2
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Chandler, 85224
Arizona
United States
Highlands Oncology Group
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Fayetteville, 72703
Arkansas
United States
UCLA Medical Center
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Los Angeles, 90095
California
United States
Central Coast Medical Oncology Corporation SC
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Santa Maria, 93454
California
United States
St Joseph Heritage Healthcare
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Santa Rosa, 94503
California
United States
Poudre Valley Hospital
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Fort Collins, 80528
Colorado
United States
Florida Cancer Research Institute Dept of Oncology
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Davie, 33328
Florida
United States
Florida Hospital Cancer Institute SC
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Orlando, 32804
Florida
United States
UF Health Cancer Center at Orlando Health
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Orlando, 32806
Florida
United States
Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. SC
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Thomasville, 31792
Georgia
United States
Moanalua Medical Center. Attn: Oncology Dept SC
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Honolulu, 96817
Hawaii
United States
Oncology Specialists, SC Advocate Medical Group-Niles
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Park Ridge, 60068-0736
Illinois
United States
Jackson Oncology Associates SC
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Jackson, 39202
Mississippi
United States
Southeast Nebraska Oncology SC
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Lincoln, 68510
Nebraska
United States
Meridian Health Systems Regulatory
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Neptune, 07753
New Jersey
United States
University of New Mexico Cancer Center SC
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Albuquerque, 87131
New Mexico
United States
CR Wood Cancer Center SC
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Glens Falls, 12801
New York
United States
Clinical Research Alliance
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Lake Success, 11042
New York
United States
NYU Langone Medical Center CV Research center NYU Langone Medical Center
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New York, 10016
New York
United States
Genesis Cancer Services SC
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Zanesville, 43701
Ohio
United States
St. Charles Cancer Center SC
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Bend, 97701
Oregon
United States
Penn State University Milton S Hershey Medical Center SC
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Hershey, 17033
Pennsylvania
United States
Millennium Oncology SC
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Houston, 77090
Texas
United States
Northern Utah Cancer Associates SC
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Ogden, 84403-3105
Utah
United States
Providence Regional Cancer Partnership
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Everett, 98201
Washington
United States
Providence Regional Cancer System SC
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Lacey, 98503
Washington
United States
Virginia Mason Medical Center-Oncology SC
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Seattle, 98101
Washington
United States
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